VARIANT II B-thalassemia 2700083

GUDID 00847817009204

VARIANT II B-thalassemia Short Program Hemoglobin A2/F Calibrator/Diluent Set

BIO-RAD LABORATORIES, INC.

Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator Haemoglobin A2 (HbA2) IVD, calibrator

• Primary Device ID: 00847817009204
• NIH Device Record Key: a877201a-8e0c-46dd-9ecb-1bb26c68ef6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VARIANT II B-thalassemia
• Version Model Number: 270-0083
• Catalog Number: 2700083
• Company DUNS: 132528295
• Company Name: BIO-RAD LABORATORIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847817009204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991127

FDA Product Code

• JPD: HEMOGLOBIN A2 QUANTITATION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-09-12

On-Brand Devices [VARIANT II B-thalassemia]

• 00847817012303: VARIANT II B-thalassemia Short Program Wash/Diluent Solution
• 00847817009914: VARIANT II B-thalassemia Short Program Analytical Cartridge
• 00847817009204: VARIANT II B-thalassemia Short Program Hemoglobin A2/F Calibrator/Diluent Set
• 00847817008634: VARIANT II B-thalassemia Short Program Elution Buffer 2
• 00847817008610: VARIANT II B-thalassemia Short Program Elution Buffer 1
• 00847817000805: VARIANT II B-Thalassemia Short Program Reorder Pack
• 00847817000447: VARIANT II B-thalassemia Short Program Reorder Pack